Maquet Medical Systems USA Bubble Sensor (REF: 70105.5720) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bubble Sensor (REF: 70105.5720)
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
Model: BS 3/8x3/32 L1.7, Correct UDI DI: 04037691816432, Incorrect UDI DI (as labeled): 04058863025148
Products Sold
Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;
Maquet Medical Systems USA is recalling Bubble Sensor (REF: 70105.5720) due to The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction Letter was sent VIA Fed-Ex 2-day delivery with signature proof of delivery to all consignees with the following instructions: Actions to be taken by the Customer: - Please examine your inventory immediately to determine if you have any affected product in your inventory. - Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to BubbleSensorUDI2023.cp@getinge.com or by faxing the form to 1-866-416-5299. - Affected Bubble Sensors do not need to be returned and can be used as-is. - Please forward this information to all current and potential Bubble Sensor users within your hospital / facility. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, GA, IL, IA, MN, NE, PA, TX, WA, WI
Page updated: Jan 10, 2026